Efficacy and safety of iopromide for excretory urography.
(Clinical Trial;Journal Article)
RATIONALE AND OBJECTIVES: Iopromide is a nonionic monomeric contrast agent. Initial laboratory and clinical data have shown that it is relatively safe. Efficacy for excretory urography has been shown to be good, comparable with other low-osmolality agents. The authors attempted to confirm these impressions in a randomized, double-blind comparison with equivalent doses of ioversol and iopamidol. METHODS: Two hundred adult patients undergoing excretory urography were studied. One hundred received iopromide, 40 received ioversol, and 60 received iopamidol (300 mg I/kg) as an intravenous bolus. Urographic films (obtained 1, 5, 15, and 20 minutes after the bolus, and postvoid) were interpreted by an observer blinded to contrast type. Visualization of renal parenchyma, pelvis and calyces, ureters, and bladder was independently assessed as excellent, good, poor, or nonvisualized. Vital signs were recorded before, 30 to 60 minutes after, and 24 hours after injection. Adverse reactions were sought, physical examinations were performed, and standard hematology and serum chemistry values were measured before and 1 day after injection; a 72-hour serum creatinine level was also measured. RESULTS: Ninety-eight percent of visualization scores were good or excellent; no significant differences among iopromide, iopamidol, and ioversol were found, nor were there any significant differences among groups in vital signs. Only one patient experienced a contrast-related physical examination change (subcutaneous extravasation). No significant changes with regard to hematology or serum chemistry values were observed; there was no contrast-induced nephropathy. Mild adverse reactions were experienced by 10% of patients; there were no significant differences in reaction rates among contrast agents. CONCLUSIONS: Iopromide at a dose of approximately 300 mg I/kg is safe and effective as an excretory urographic agent and is comparable in performance with ioversol and iopamidol.
Newhouse, JH; Landman, J; Lang, E; Amis, ES; Goldman, S; Khazan, R; Leder, R; Hedgcock, M
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